Vaccination of COVID-19-convalescent individuals may generate 'hybrid' immunity of enhanced magnitude, durability, and cross-reactive breadth. Our primary goal was to characterize hybrid antibody (Ab) responses in a patient cohort infected with ancestral Wuhan-Hu-1 virus and vaccinated between 6 and 10 months later with the Wuhan-Hu-1-based BNT162b2 mRNA vaccine. We were particularly interested in determining the efficacy of neutralizing Ab responses against subsequently emergent SARS-CoV-2 variants. Sera collected at 3-monthly intervals over a period of 12 months were analyzed by ELISA for SARS-CoV-2 RBD-specific Ab responses, and also for neutralizing Ab activity using pseudovirus-based neutralization assays. We found that convalescent RBD-reactive IgG and IgA Ab responses did not decline significantly through 9 months post-diagnosis. These responses improved significantly following vaccination and remained elevated through at least 12-months. SARS-CoV-2 neutralizing Ab activity was detected in convalescent sera through 9 months post-diagnosis, although it trended downwards from 3 months. Neutralizing Ab activity against the Wuhan-Hu-1 strain was significantly improved by vaccination, to levels that persisted through the end of the study. However, sera collected from vaccinated convalescent subjects also had significant neutralization activity against Delta B.1.617.2 and Omicron variants that persisted for at least 2-3 months, unlike sera from unvaccinated convalescent controls. Thus, vaccination of Wuhan-Hu-1-convalescent individuals with the BNT162b2 vaccine improved and sustained protective neutralizing Ab activity against SARS-CoV-2, including cross-reactive neutralizing activity against variants that emerged months later.

Human papillomavirus (HPV) infection is a major cause of cervical cancer. Studies showed HPV carcinogenesis may be induced by oxidative stress affecting the host immune system. The objective of this study is to evaluate levels of four circulating oxidative stress biomarkers associated with the HPV infection, persistence, and cervical lesion status in women. The three serum biomarkers measuring oxidative damage to biomolecules (8-oxodG, 8-oxo-7,8-dihydro-2'-deoxyguanosine [8-oxodG] for DNA, 4-hydroxy-2-nonenal [4-HNE] for lipid, and protein carbonyl [PC] for protein) and one antioxidant (glutathione, GSH) collected from 38 women were evaluated. The PC levels were significantly higher for women with oncogenic HPV infection (p = 0.047) and persistence (p = 0.053) based on the unadjusted linear model. In particular, women with ≥3 oncogenic HPV types had a higher PC level than those without HPV infection (p = 0.041). Women with low-grade squamous intraepithelial lesions showed an elevated PC (p = 0.058). These trends remained similar after adjusting for age. The GSH levels were lower for women infected with ≥3 oncogenic HPV types based on age-adjusted results (p = 0.061). This study supported that serum PC was associated with HPV infection, persistence, and cervical lesions, so it can potentially be used to monitor HPV carcinogenesis. Further large-scale studies will be needed to confirm these findings.

Abstract Background Guidelines recommend the human papillomavirus (HPV) vaccine for all adults through age 26, shared clinical decision-making for those aged 27 through 45 years who are inadequately vaccinated, and for all people with HIV up to age 45 years. The intent of this study is to evaluate HPV vaccination rates at the HIV Outpatient Program (HOP) at University Medical Center in New Orleans. Methods Immunization records from patients aged 18 through 45 years attending a physician visit in the LSU Infectious Diseases fellows’ HIV primary care clinic at HOP in 2022 were reviewed. The purpose of this project was to assess compliance with HPV vaccination recommendations among the infectious diseases fellows. Results Among patients under age 27, 15 of 21 visits (71%) had completed HPV vaccines series. 4 visits (19%) had incomplete status and 2 visits (10%) did not have any HPV vaccines record. Among patients aged 27 through 45 years, 73 of 194 visits (38%) had completed HPV vaccines series. 34 visits (18%) had partial vaccination records and 87 visits (45%) had no records. Conclusion Vaccination compliance among the LSU ID fellows was less than ideal, only 71% of visits for patient aged up to 27 years attending LSU ID fellows’ clinic had completed HPV vaccine series, compared to the Health People 2020 recommendation of 80%. Only 38% of visits for patients aged 27 through 45 years are fully vaccinated with HPV vaccines. Patients in this age group are often labeled “aged out” for HPV vaccines by health maintenance reminders however, due to having HIV, they are still eligible and should be vaccinated. These results led to the institution of quality improvement project to address HPV vaccinations. This intervention will focus on educating all HOP providers about the vaccination recommendations and updating the health maintenance care gaps reminder in the electronic medical record. Disclosures All Authors: No reported disclosures

The oral microbiome can be an important predictor of health and disease. For persons living with HIV (PLWH), HIV and highly active antiretroviral therapy (ART) may have a significant influence on their oral microbiome.

Mortality in COVID-19 cases was strongly associated with progressive lung inflammation and eventual sepsis. There is mounting evidence that live attenuated vaccines commonly administered during childhood, also provide beneficial non-specific immune effects, including reduced mortality and hospitalization due to unrelated infections. It has been proposed that live attenuated vaccine-associated non-specific effects are a result of inducing trained innate immunity to function more effectively against broader infections. In support of this, our laboratory has reported that immunization with a live attenuated fungal strain induces a novel form of trained innate immunity which provides protection against various inducers of sepsis in mice via myeloid-derived suppressor cells. Accordingly, we initiated a randomized control clinical trial with the live attenuated Measles, Mumps, Rubella (MMR) vaccine in healthcare workers in the greater New Orleans area aimed at preventing/reducing severe lung inflammation/sepsis associated with COVID-19 (ClinicalTrials.gov Identifier: NCT04475081). Included was an outcome to evaluate the myeloid-derived suppressor cell populations in blood between those administered the MMR vaccine vs placebo. The unanticipated emergency approval of several COVID-19 vaccines in the midst of the MMR clinical trials eliminated the ability to examine effects of the MMR vaccine on COVID-19-related health status. Unfortunately, we were also unable to show any impact of the MMR vaccine on peripheral blood myeloid-derived suppressor cells due to several inherent limitations (low percentages of blood leukocytes, small sample size), that also included a collaboration with a similar trial (CROWN CORONATION; ClinicalTrials.gov Identifier: NCT04333732) in St. Louis, MO. In contrast, monitoring the COVID-19 vaccine response in trial participants revealed that high COVID-19 antibody titers occurred more often in those who received the MMR vaccine vs placebo. While the trial was largely inconclusive, lessons learned from addressing several trial-associated challenges may aid future studies that test the non-specific beneficial immune effects of live attenuated vaccines.

This study evaluates associations between diet quality using the Healthy Eating Index and genital HPV infection in women. The results showed women who did not eat fruits, dark-green vegetables, and beans had an elevated risk of genital oncogenic HPV infection. Background Most cervical cancers are directly linked to oncogenic or high-risk human papillomavirus (HR-HPV) infection. This study evaluates associations between diet quality and genital HPV infection in women. Methods This study included 10 543 women from the 2003-2016 National Health and Nutrition Examination Survey. The outcome was the genital HPV infection status (HPV-negative, low-risk [LR] HPV, and HR-HPV). Dietary quality was evaluated using the Healthy Eating Index (HEI), in which a higher score indicates a better diet quality. Results Women who did not consume total fruits (15.8%), whole fruits (27.5%), or green vegetables and beans (43%) had a significantly higher risk of HR-HPV infection than women who complied with the Dietary Guidelines for Americans (HR-HPV odds ratio = 1.76, 1.63, and 1.48 for a HEI score of 0 vs 5, respectively) after adjusting confounding factors. Similar results of these food components on LR-HPV infection were found. In addition, intake of whole grains and dairy was inversely associated with LR-HPV infection. Conclusions This study showed that women who did not eat fruits, dark-green vegetables, and beans had a higher risk of genital HR-HPV infection. Intake of these food components is suggested for women to prevent HPV carcinogenesis.

OBJECTIVE:HIV disease is evolving with more HIV+ persons experiencing a high quality of life with well-controlled viremia. We recently enrolled a large cohort of HIV+ and clinically relevant HIV- persons for oral microbiome analyses that included a questionnaire related to oral hygiene and recreational behaviors. Here, the questionnaire responses were analyzed for behavioral trends within the cohort, together with trends over time by comparison to a previous geographically centered HIV+ cohort.METHODS:Data were collected by questionnaire at baseline visits as cross-sectional assessments. Multivariable analyses were conducted for associations of HIV status as well as age, race, and sex, on oral hygiene/recreational behaviors.RESULTS:HIV+ subjects had reduced brushing frequency, but increased incidence of past cleanings and frequency of dry mouth, compared to the HIV- subjects. Within the entire cohort, positive associations were identified between age and several oral hygiene practices, and between age, race, and sex for several recreational behaviors. In comparison to the historical cohort, the contemporary HIV+ cohort participated in fewer high-risk behaviors, but with similar trends for smoking and oral hygiene practices.CONCLUSION:HIV status had little association with oral hygiene and recreational behaviors despite several differences in age, race, and sex. Behavioral trends over time support a higher quality of life in people currently living with HIV.

The COVID-19 pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) impacted healthcare, the workforce, and worldwide socioeconomics. Multi-dose mono- or bivalent mRNA vaccine regimens have shown high efficacy in protection against SARS-CoV-2 and its emerging variants with varying degrees of efficacy. Amino acid changes, primarily in the receptor-binding domain (RBD), result in selection for viral infectivity, disease severity, and immune evasion. Therefore, many studies have centered around neutralizing antibodies that target the RBD and their generation achieved through infection or vaccination. Here, we conducted a unique longitudinal study, analyzing the effects of a three-dose mRNA vaccine regimen exclusively using the monovalent BNT162b2 (Pfizer/BioNTech) vaccine, systematically administered to nine previously uninfected (naïve) individuals. We compare changes in humoral antibody responses across the entire SARS-CoV-2 spike glycoprotein (S) using a high-throughput phage display technique (VirScan). Our data demonstrate that two doses of vaccination alone can achieve the broadest and highest magnitudes of anti-S response. Moreover, we present evidence of novel highly boosted non-RBD epitopes that strongly correlate with neutralization and recapitulate independent findings. These vaccine-boosted epitopes could facilitate multi-valent vaccine development and drug discovery.

The 2022 outbreak of mpox in Louisiana was limited to just >300 cases, perhaps an unexpected outcome given the state's high rates of HIV and other sexually transmitted infections (STIs). We aimed to describe the local outbreak within two health centers in the New Orleans region, partnering with the Louisiana Department of Health to offer additional statewide data. We reviewed charts of persons testing positive for mpox in New Orleans from July to November 2022 at two local health centers that together accounted for half of local cases. We abstracted data on HIV status, immune function [CD4 count, viral load (VL)], antiretroviral therapy regimen, symptoms and severity of infection, vaccination status, and whether tecovirimat was administered. We present local data relative to statewide data (July 2022-January 2023). Of 103 individuals in our network for whom charts were reviewed, 96 (93%) identified as male, 52 (50%) were Black, and 69 (67%) had HIV, including 12 (17%) with uncontrolled HIV (CD4 < 200 cells/mm3 or VL >200 copies/mL). The most common presenting symptoms were rash (n = 71, 69%), fever (n = 36, 35%), and rectal pain (n = 33, 32%). Of six (6%) patients hospitalized, four (67%) were persons with HIV (PWH). Two were hospitalized for severe mpox infection with >100 lesions at presentation; both were PWH, and one had uncontrolled infection. Across the state, 307 cases have been identified and 24 have been hospitalized. Of those hospitalized, 18 (75%) were PWH, including 9 (50%) with uncontrolled HIV. The demographic data from Louisiana, a state with high prevalence of STIs and HIV/AIDS, are consistent with prior reports describing the 2022 mpox outbreak. Our results contribute to accumulating data on the severity of infection in individuals with HIV-related immunocompromise.

SARS-CoV-2 mRNA vaccines are administered as effective prophylactic measures for reducing virus transmission rates and disease severity. To enhance the durability of post-vaccination immunity and combat SARS-CoV-2 variants, boosters have been administered to two-dose vaccinees. However, long-term humoral responses following booster vaccination are not well characterized. A 16-member cohort of healthy SARS-CoV-2 naïve participants were enrolled in this study during a three-dose BNT162b2 vaccine series. Serum samples were collected from vaccinees over 420 days and screened for antigen (Ag)-specific antibody titers, IgG subclass distribution, and neutralizing antibody (nAb) responses. Vaccine boosting restored peak Ag-specific titers with sustained α-RBD IgG and IgA antibody responses when measured at six months post-boost. RBD- and spike-specific IgG4 antibody levels were markedly elevated in three-dose but not two-dose immune sera. Although strong neutralization responses were detected in two- and three-dose vaccine sera, these rapidly decayed to pre-immune levels by four and six months, respectively. While boosters enhanced serum IgG Ab reactivity and nAb responses against variant strains, all variants tested showed resistance to two- and three-dose immune sera. Our data reflect the poor durability of vaccine-induced nAb responses which are a strong predictor of protection from symptomatic SARS-CoV-2 infection. The induction of IgG4-switched humoral responses may permit extended viral persistence via the downregulation of Fc-mediated effector functions.

Background: Most cervical cancers are directly linked to infection with Human Papillomavirus (HPV), especially oncogenic or high-risk HPVs (HR-HPVs). Studies showed that high levels of several nutritional antioxidants (such as vitamin A, B2, E, and folate) are inversely associated with HR-HPV genital infection among women. These antioxidants are associated with dietary patterns, but associations between dietary patterns and genital HPV infection in women are understudied. To address this gap, this study aims to evaluate associations between healthy eating quality and patterns and genital HPV infection in women. Method: The study included 10,543 women aged 18-59 years from the 14-year (2003-2016) National Health and Nutrition Examination Survey, a US population-based survey. The outcome variable is the HPV infection status (HPV-negative, low-risk [LR] HPV, and HR-HPV), measured based on vaginal swabs. The dietary patterns were evaluated using the Healthy Eating Index (HEI), which measures diet quality based on 13 food components based on key recommendations of the Dietary Guidelines for Americans. A higher HEI score (overall score: range 0-100 or component score: 0-5 or 10) indicates a better diet quality. Associations between the HEI scores and HPV infections were evaluated using the survey weighting multinomial logistic regression adjusting for potential confounding factors. Results: The mean HEI score for US women is 54.5 (standard error=0.4). Women with vaginal HPV infection tended to have a low HEI score (p<0.001). The mean HEI scores for women with HPV-negative, LR-HPV, and HR-HPV are 55.6, 53.1, and 42.2, respectively. However, the association with the overall HEI score became non-statistically significant after adjusting the confounding factors (such as age, smoking, and sexual behavior). The women with the highest intake (score=5 out of 5) of greens and beans and total fruit had a lower risk of HR-HPV (OR=0.70 vs. score=0, p<0.001, and OR=0.57, p<0.01, respectively) adjusted for confounding factors. A high intake of whole grains and dairy can lower the risk of LR-HPV but not HR-HPV. In addition, women with a high score of total protein had a higher risk of HR-HPV (OR=2.1 for score=5 vs. 0-2, p<0.05). Conclusion: This study showed that healthy eating patterns are inversely associated with vaginal HPV infection for US women. These findings can provide valuable insight into developing an intervention to prevent HPV infection from getting established or HPV persistence among the population at higher risk for cervical cancer. Citation Format: Huiyi Lin, Qiufan Fu, Tung-sung Tseng, Krzysztof Reiss, Joseph Su, Martin J. Ronis, Jennifer E. Cameron, Michael E. Hagensee. Impact of healthy eating patterns on HPV infection in women [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 2261.

Background: COVID-19 pandemic remains a global emergencies. Vaccines against the virus SARS-CoV-2 have been shown to reduce incidence and severe complications from COVID-19 infection. Previous studies have shown that patients receiving active cancer therapies for solid or hematological malignancies demonstrated a significantly lower response after initial 2- doses of vaccines, in comparison to the general population. There is limited data on the immune response to a 3rd dose of the mRNA COVID-19 vaccine in patients receiving active treatment for malignancies and especially in minorities. This study aims to assess immune response against SARS-CoV-2 after 3rd dose of mRNA vaccination in this particular population. Study Design: Between September 2021 and January 2022, 119 patients on active cancer treatments at University Medical Center- New Orleans were enrolled on this prospective study (IRB Protocol 641). Plasma samples were collected before and approximately 3-6 weeks after the 3rd vaccine dose. 40 patients received the 3rd vaccine dose and completed the study. Serum antibody testing by ELISA was performed. IgG response was assessed by testing for antibodies against the wild type SARS-CoV-2 proteins RBD and N (natural COVID-19 infection). Results: Patient demographics consisted of 66.4% African American, 27.3% Caucasian, and 6.4% others. On the average, there was an approximately 8x fold increase in titer response after the 3rd dose of SAR-CoV-2 vaccination. Titer response was highest in patients on immunotherapy compared to those on cytotoxic chemotherapy. Higher titer response were also observed in patients with metastatic cancers compared to non-metastatic cancers, in African Americans compared to other ethnicities, and males. Patients who received the 3rd vaccine dose six months after initial 2-dose series tended to mount higher titer response compared to those who received their 3rd dose within 3 months. None of study subjects were hospitalized for COVID-19 infection during the duration of this study. Conclusion: 3rd dose mRNA vaccines against SAR-CoV-2 were effective in preventing infections and complications from COVID-19 infection in patients and ethnic minorities who are on active treatment for solid and liquid malignancies. Our study is limited by the small number of subjects. Studies are being conducted to evaluate duration of antibodies response in this patient group compared to general population.

Nutrient deficits have been repeatedly linked to cervical human papillomavirus (HPV) persistence, cervical neoplasia, and cervical cancer in case-control studies. This study sought to examine the relationship between overall diet quality and dietary components with the spontaneous resolution of cervical HPV over one year. A prospective observational cohort study was performed. Women with low-grade cervical cytology and/or positive HPV test completed a 24-hour dietary recall, from which the Healthy Eating Index (HEI)-2010, a score of overall diet quality, and scores in dietary categories were calculated. Participants were managed clinically according to national management guidelines. Those whose subsequent testing demonstrated normalization of cytology and/or HPV testing ("HPV resolution") were compared to those whose abnormalities persisted or progressed ("HPV non-resolution"). Twenty-six women were included in the HPV resolution group and 38 in the non-resolution group. They were observed for a median of 428 and 412 day, respectively (p = 0.09). There was no difference in overall diet quality between the groups. Intake of total and whole fruit, and seafood/plant protein were associated with HPV resolution in a logistic regression model (all p < 0.05). These findings could have important implications for the counseling and management of individuals with HPV infection of the cervix.

Background. Human papillomavirus (HPV) infection is a major cause of cervical cancer. Studies showed the onset of HPV carcinogenesis may be induced by oxidative stress affecting the host immune system. The association between antioxidants and oncogenic HPV remains unclear. In this study, we aim to identify antioxidants associated with vaginal HPV infection in women. Methods. The associations between the 15 antioxidants and vaginal HPV infection status (no, low-risk [LR], and high-risk [HR] HPV) were evaluated using 11 070 women who participated in the 2003-2016 National Health and Nutrition Examination Survey (NHANES). Results. We identified serum albumin and 4 dietary antioxidants (vitamin A, B2, E, and folate) inversely associated with HR-HPV infection. Women with a low level of albumin (<= 39 g/L) have a significantly higher risk of HR-HPV (odds ratio [OR]=1.4, P=.009 vs >44 g/L). A Nutritional Antioxidant Score (NAS) was developed based on these 4 dietary antioxidants. The women with the lowest quartile NAS had a higher chance of HR-HPV (OR=1.3, P=.030) and LR-HPV (OR=1.4, P=.002) compared with the women with the highest quartile NAS. Conclusions. We identified 5 antioxidants negatively associated with vaginal HR-HPV infection in women. Our findings provide valuable insights into understanding antioxidants' impact on HPV carcinogenesis.

The oral microbiome is considered an important factor in health and disease. We recently reported significant effects of HIV and several other clinical variables on the oral bacterial communities in a large cohort of HIV-positive and -negative individuals. The purpose of the present study was to similarly analyze the oral mycobiome in the same cohort. To identify fungi, the internal transcribed spacer 2 (ITS2) of the fungal rRNA genes was sequenced using oral rinse samples from 149 HIV-positive and 88 HIV-negative subjects that had previously undergone bacterial amplicon sequencing. Quantitative PCR was performed for total fungal content and total bacterial content. Interestingly, samples often showed predominance of a single fungal species with four major clusters predominated by Candida albicans, Candida dubliniensis, Malassezia restricta, or Saccharomyces cerevisiae. Quantitative PCR analysis showed the Candida-dominated sample clusters had significantly higher total fungal abundance than the Malassezia or Saccharomyces species. Of the 25 clinical variables evaluated for potential influences on the oral mycobiome, significant effects were associated with caries status, geographical site of sampling, sex, HIV under highly active antiretroviral therapy (HAART), and missing teeth, in rank order of statistical significance. Investigating specific interactions between fungi and bacteria in the samples often showed Candida species positively correlated with Firmicutes or Actinobacteria and negatively correlated with Fusobacteria, Proteobacteria, and Bacteroidetes. Our data suggest that the oral mycobiome, while diverse, is often dominated by a limited number of species per individual; is affected by several clinical variables, including HIV positivity and HAART; and shows genera-specific associations with bacterial groups. IMPORTANCE The oral microbiome is likely a key element of homeostasis in the oral cavity. With >600 bacterial species and >160 fungal species comprising the oral microbiome, influences on its composition can have an impact on both local and systemic health. We recently reported significant effects of HIV and several other clinical variables on the oral bacterial community in a large cohort of HIV-positive and -negative subjects. We describe here a comprehensive analysis of the oral mycobiome in the same cohort. Similar to the bacterial community, HIV under highly active antiretroviral therapy (HAART) had a significant impact on the mycobiome composition, but with less impact compared to other clinical variables. Additionally, unlike the oral bacterial microbiome, the oral mycobiome is often dominated by a single species with 4 major clusters of fungal communities. Together, these results suggest the oral mycobiome has distinct properties compared with the oral bacterial community, although both are equally impacted by HIV.

This Basic Science Workshop addressed the oral microbiome. At the 7th World Workshop on Oral Health & Disease in HIV/AIDS in India in 2014, some aspects of the human microbiome were discussed, and research questions formulated. Since that time, there have been major advances in technology, which have stimulated a number of publications on many aspects of the human microbiome, including the oral cavity. This workshop aimed to summarize current understanding of the "normal" microbiome of the oral cavity compared to that during HIV infection, and how oral immune factors and other clinical variables alter or control the oral microbiome. An important question is whether successful treatment with anti-retroviral therapy, which leads to a significant drop in viral loads and immune reconstitution, is associated with any change or recovery of the oral microbiome. Additionally, the workshop addressed the issue of which parameters are most appropriate/correct to evaluate the oral microbiome and how clinically relevant are shifts/changes in the oral microbiome. The workshop evaluated current knowledge in five research areas related to five basic questions and identified further topics where further research is required.

PURPOSE:Although infection with high-risk human papillomavirus (HPV) is a prerequisite for cervical cancer development, HPV infection is not sufficient to promote cancer in the majority of infected women. We tested the hypothesis that human herpesviruses might cooperate with HPV to promote the development of cervical dysplasia, an early indicator of cervical cancer development.METHODS:This study used archived specimens from a cohort of human immunodeficiency virus (HIV)-seropositive women seeking gynecological care at the Medical Center of New Orleans, Louisiana. Viral DNA was detected by PCR amplification and risk of abnormal cervical cytology was determined in relation to virus test results.RESULTS:Consensus human herpesvirus PCR with herpes speciation by restriction endonuclease digestion revealed Epstein-Barr virus (EBV) to be the most prevalent herpesvirus in cervicovaginal lavage specimens. Further analysis using an EBV-specific PCR assay and cervical swab specimens demonstrated an approximately fourfold increased risk of abnormal cervical cytology in women testing positive for cervical EBV and high-risk HPV compared to women testing positive for high-risk HPV alone. This relationship was independent of markers of advancing HIV disease.CONCLUSION:Cervical shedding of EBV appears to predict a greater risk of cervical dysplasia in HIV-infected women with a high-risk HPV infection.

Abstract Background: The purpose of this randomized trial was to examine the feasibility of using home self-sampling for HPV testing to screen for cervical cancer, as compared to HPV samples obtained by a physician or nurse practitioner during a clinical exam. Methods: Two LSU study sites were used, New Orleans and Shreveport, LA. Stratified, permuted blocks randomization was used to allocate patients to one of two methods of home sampling: a standard tampon inserted and worn for two hours, or an easy-to-use vaginal swab device (HerSwab®). All self- collected and clinical were tested for HPV 16 and 18 subtypes and other high-risk subtypes. Each self-collected sample was compared to the patient's clinical sample using McNemarâ' paired chi-squared test. Tampon and self-collected swab samples were compared using an unpaired chi-squared test. Results: A total of one hundred and seventy-four (174) eligible subjects were recruited. Ninety-five subjects were recruited from Shreveport and 79 from New Orleans. The age of the women subjects ranged from 21 to 69, with a mean age of 47 years. The predominant race was African American, 73%, with 22% white and 5% Asian, mixed race or unknown. Hispanic or Latino ethnicity was reported as 4%. Overall, 66% of home-collected specimens were returned for processing. The percent positive specimens was approximately the same, regardless of specimen source, e.g., clinical (13.5% positive), tampon (14.5% positive) or swab (15% positive). There was no statistical difference between the positive specimen rates of tampon and swab methods. By oversight, 11 clinical specimens were not collected for HPV testing. Six women had a positive self-test, but their clinical test results were not positive. All the clinical samples were sufficient for valid DNA analysis. Only one of the home swab specimens was insufficient, but 15 of the tampon specimens were insufficient. This difference is highly statistically significant, p< 0.0001 by Fisher's exact test. Also, as mentioned above, the return rate was better for the swab method. Fifty-five women answered the satisfaction questionnaire. Participants assigned to the tampon use complained about the procedure verbally to the study nurse, although the formal questionnaire did not reflect this. None reported problems with the swab method. Conclusion: The self-collected HPV specimens were not significantly different from the clinically collected specimens, although the tampon method had more unreturned specimens and significantly more specimens of insufficient quality for testing. Citation Format: Jerry McLarty, Donna Williams, Susan Loyd, Michael Hagensee. Cervical HPV testing with two home self-collection methods compared to a standard clinical-collection method [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr B116.

Persons infected with HIV are particularly vulnerable to a variety of oral microbial diseases. Although various study designs and detection approaches have been used to compare the oral microbiota of HIV-negative and HIV-positive persons, both with and without highly active antiretroviral therapy (HAART), methods have varied, and results have not been consistent or conclusive. The purpose of the present study was to compare the oral bacterial community composition in HIV-positive persons under HAART to an HIV-negative group using 16S rRNA gene sequence analysis. Extensive clinical data was collected, and efforts were made to balance the groups on clinical variables to minimize confounding. Multivariate analysis was used to assess the independent contribution of HIV status. Eighty-nine HIV-negative participants and 252 HIV-positive participants under HAART were sampled. The independent effect of HIV under HAART on the oral microbiome was statistically significant, but smaller than the effect of gingivitis, periodontal disease, smoking, caries, and other clinical variables. In conclusion, a multivariate comparison of a large sample of persons with HIV under HAART to an HIV-negative control group showed a complex set of clinical features that influenced oral bacterial community composition, including the presence of HIV under HAART.

BACKGROUND:The purpose of this study was to compare the outcomes of 2 self-collection methods to detect cervical human papillomavirus (HPV) DNA with outcomes from a standard clinical method. The standard method samples were collected by a clinician at a routine pelvic examination. Self-samples were taken at home and mailed to the clinical laboratory.METHODS:The 2 self-collection methods were a tampon-based method and a swab-based method using a commercial device, an Eve Medical HerSwab. All HPV samples were processed by a clinical laboratory using the Food and Drugs Administration approved Roche Cobase HPV method, which specifically identifies HPV 16, HPV 18, and a set of 12 other high-risk subtypes. Patients were recruited from 2 cancer screening clinics 2015 to 2017. All patients signed an informed consent. Screening outcomes, such as prevalence, percent agreement with standard, sensitivity, and specificity, were calculated for each self-collection method. Measures of similarity between self and standard collection outcomes, Cohen's κ, percent concordance, McNemar equivalence, and others were tested statistically.RESULTS:One hundred seventy-four patients were randomized. The prevalence of 1 or more positive HPV high-risk subtypes from the standard clinical specimens was 13.5%. All clinical specimens were sufficient for valid HPV detection. For the tampon method, 15 (27%) of the specimens were insufficient quality. Only 1 (2%) swab specimen was insufficient. Only the swab self-collection method was found to be statistically noninferior to the clinical method. The tampon method had an unacceptably high rate of insufficient quality specimens and also failed the equivalency tests.CONCLUSIONS:The swab home collection samples were equivalent to the clinical samples, but the tampon method had an unacceptably high rate of specimens insufficient for HPV detection.